Postnatal Pulmonary AdaptationPhase 4SAISTYNCT01978418
Inhaled Salbutamol in Elective Caesarean Section
A Phase 4 study testing salbutamol in people with Postnatal Pulmonary Adaptation and Cesarean Section, run by Sture Andersson at 1 site in Finland.
Trial summary
The lungs of the fetus are filled with fluid and it is essential that fetal lung fluid is cleared at birth. This process is mediated through the activation of airway epithelial sodium channels (ENaC). In animals, ENaC is considered crucial for postnatal pulmonary adaptation. Read more about this study
- Who is it for?
- Ages Up to 1 hourHealthy volunteers can take part
- Conditions the study is for
- Postnatal Pulmonary Adaptation, Cesarean Section
- What is being tested?
- salbutamol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteFinland
- Study dates
- Nov 2013to Dec 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 1 hour
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- healthy singleton pregnancy
- Cesarean section at 37 + 0 to 41 + 6 gestational weeks
Who cannot join
- clinically significant congenital malformations
- birth weight < 2000 grams
- intubation
- 200 bp for more than 5 min
- relevant medication of the mother, e.g. albetol, beta-agonists (e.g. salbutamol, salmeterol), corticosteroids
- the suspicion of/confirmed pneumothorax or infection
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Women's Hospital
Helsinki, 00029
Cecilia Janér, MD, +35894711, cecilia.janer@helsinki.fi
Otto M Helve, MD, PhD, +358505824426, otto.helve@helsinki.fi
About this study
The lungs of the fetus are filled with fluid and it is essential that fetal lung fluid is cleared at birth. This process is mediated through the activation of airway epithelial sodium channels (ENaC). In animals, ENaC is considered crucial for postnatal pulmonary adaptation. In humans, postnatal ENaC expression is dependent on gestational age and its activity, measured as nasal potential difference, correlates with lung compliance. Therefore, in the human newborn infant ENaC may be important for physiologic postnatal adaptation. The activity of ENaC is increased by beta-agonists, such as salbutamol. We hypothesize that low pulmonary expression or activity of ENaC in the perinatal period causes delayed clearance of lung fluid and thereby contributes to the risk for development of transient tachypnea of the newborn (TTN) in term infants born by Caesarean section (CS).
Read the detailed description
We hypothesize that low pulmonary expression or activity of ENaC in the perinatal period causes delayed clearance of lung fluid and thereby contributes to the risk for development of transient tachypnea of the newborn (TTN) in term infants born by Caesarean section (CS). The aim of this study is to evaluate whether the respiratory status, measured by a transthoracic ultrasound method and lung compliance, of newborns infants born by CS can be improved by inhaled salbutamol at 30-60 minutes of age. 62 infants will be included and randomized to receive salbutamol or placebo-inhalations in a double-blind manner.
- Conditions
- Postnatal Pulmonary Adaptation, Cesarean Section
- Being tested
- salbutamol, Placebo
- Keywords
- Lung fluid, Postnatal adaptation, Salbutamol, Albuterol, Epithelial Sodium Channel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
salbutamolDrug
Also called Inhaled Ventoline (Evohaler) 0,1 mg/dos
Medication given once as a dose of 4 puffs at 30-60 minutes of age
PlaceboDrug
Also called Placebo, manufactured by GSK Finland
Placebo given once as a dose of four puffs at 30-60 minutes of age
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo is administered once, at 30-60 minutes of age Receives: Drug: Placebo |
| Intervention | Active comparator | Salbutamol 0,4 mg inhalation, given once at 30-60 minutes of age Receives: Drug: salbutamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate whether lung ultrasound at 30-60 minutes of birth is improved at 3-6 hours of birth
To evaluate whether the respiratory status measured by a transthoracic ultrasound method of newborn infants born by CS can be improved by inhaled salbutamol at 30-60 minutes of age.
Measured: 6 hours
Secondary outcomes (4)
To evaluate whether lung compliance measured at 3-6 hours is improved by inhaled salbutamol at 30-60 minutes of age
To evaluate whether lung compliance of newborn infants born by CS can be improved by inhaled salbutamol at 30-60 minutes of age.
Measured: 6 hours
Decrease in respiratory rate at 3-6 hours of age
To see whether respiratory rate is decreased in infants receiving salbutamol at 30-60 minutes of age
Measured: 6 hours
To see whether there is a correlation between airway ENaC expression measured at 30-60 minutes of age and consequent lung fluid content at 3-6 hours of age
Measured: 6 hours
Whether cord blood cortisol concentrations correlate with expression of ENaC and further, with decrease in lung fluid content at 3-6 hours of age
whether cord blood cortisol concentrations correlate with expression of ENaC and further, with decrease in lung fluid content at 3-6 hours of age
Measured: 6 hours of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionSep 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postnatal Pulmonary AdaptationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sture Andersson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sture Andersson, Helsinki University Central Hospital
- Investigators
- Sture Andersson, MD, PhD, Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01978418
- Sponsor's protocol ID
- SAISTY-1
- Acronym
- SAISTY
- Status last verified
- Dec 2014
- First submitted
- 31 Oct 2013
- Last updated
- 8 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhaled Salbutamol in Elective Caesarean Section
- ClinicalTrials.gov ID
- NCT01978418
- Acronym / sponsor ID
- SAISTY / SAISTY-1
- Conditions
- Postnatal Pulmonary Adaptation, Cesarean Section
- Keywords
- Lung fluid, Postnatal adaptation, Salbutamol, Albuterol, Epithelial Sodium Channel
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Sture AnderssonUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 7 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The lungs of the fetus are filled with fluid and it is essential that fetal lung fluid is cleared at birth. This process is mediated through the activation of airway epithelial sodium channels (ENaC). In animals, ENaC is considered crucial for postnatal pulmonary adaptation. In humans, postnatal ENaC expression is dependent on gestational age and its activity, measured as nasal potential difference, correlates with lung compliance. Therefore, in the human newborn infant ENaC may be important for physiologic postnatal adaptation. The activity of ENaC is increased by beta-agonists, such as salbutamol. We hypothesize that low pulmonary expression or activity of ENaC in the perinatal period causes delayed clearance of lung fluid and thereby contributes to the risk for development of transient tachypnea of the newborn (TTN) in term infants born by Caesarean section (CS).
Detailed description
We hypothesize that low pulmonary expression or activity of ENaC in the perinatal period causes delayed clearance of lung fluid and thereby contributes to the risk for development of transient tachypnea of the newborn (TTN) in term infants born by Caesarean section (CS). The aim of this study is to evaluate whether the respiratory status, measured by a transthoracic ultrasound method and lung compliance, of newborns infants born by CS can be improved by inhaled salbutamol at 30-60 minutes of age. 62 infants will be included and randomized to receive salbutamol or placebo-inhalations in a double-blind manner.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo is administered once, at 30-60 minutes of age |
| Intervention | Active comparator | Drug: salbutamolSalbutamol 0,4 mg inhalation, given once at 30-60 minutes of age |
Who may qualify
- Ages
- Up to 1 hour
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- healthy singleton pregnancy
- Cesarean section at 37 + 0 to 41 + 6 gestational weeks
Key exclusion criteria (6 listed)
- clinically significant congenital malformations
- birth weight < 2000 grams
- intubation
- 200 bp for more than 5 min
- relevant medication of the mother, e.g. albetol, beta-agonists (e.g. salbutamol, salmeterol), corticosteroids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| salbutamolAlso: Inhaled Ventoline (Evohaler) 0,1 mg/dosMedication given once as a dose of 4 puffs at 30-60 minutes of age | Drug | Intervention |
| PlaceboAlso: Placebo, manufactured by GSK FinlandPlacebo given once as a dose of four puffs at 30-60 minutes of age | Drug | Placebo |
Primary outcome
To evaluate whether lung ultrasound at 30-60 minutes of birth is improved at 3-6 hours of birth
Time frame: 6 hours
To evaluate whether the respiratory status measured by a transthoracic ultrasound method of newborn infants born by CS can be improved by inhaled salbutamol at 30-60 minutes of age.
4 secondary outcomes
To evaluate whether lung compliance measured at 3-6 hours is improved by inhaled salbutamol at 30-60 minutes of age
Time frame: 6 hours
Decrease in respiratory rate at 3-6 hours of age
Time frame: 6 hours
To see whether there is a correlation between airway ENaC expression measured at 30-60 minutes of age and consequent lung fluid content at 3-6 hours of age
Time frame: 6 hours
Whether cord blood cortisol concentrations correlate with expression of ENaC and further, with decrease in lung fluid content at 3-6 hours of age
Time frame: 6 hours of age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2014.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sture Andersson, MD, PhD principal investigator
Helsinki University Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing salbutamol in people with Postnatal Pulmonary Adaptation and Cesarean Section, run by Sture Andersson at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cecilia Janér, MD (+35894711, cecilia.janer@helsinki.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate whether lung ultrasound at 30-60 minutes of birth is improved at 3-6 hours of birth (time frame: 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2014.